Module 1 2021

25/06/2021

Use electronic submissions whenever you can

• We’ll discuss later about the documented acceptability of electronic submissions around the world • However, most agency reviewers are now used to working electronically • Even if their regulations say the submission must be in paper, you can bet that they will create their assessment report in MS Word and e-mail it to you when they are done • Therefore, always put the electronic submission into the package for the agency, most reviewers will use it in preference to the paper

The Organisation for Professionals in Regulatory Affairs

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Make your internal use part of the strategy

• A good electronic submission and well authored documents are a valuable resource to your company • Well managed documents will help your own internal business • Combine these benefits into your strategy and ensure that your company gets the most from the investment in working electronically

The Organisation for Professionals in Regulatory Affairs

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